Model Number 72404310 |
Device Problems
Collapse (1099); Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/27/2020 |
Event Type
Injury
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Event Description
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It was reported that the patient had the inflatable penile prosthesis pump component removed due to a malfunctioning, freezing pump.A new inflatable penile prosthesis pump component was implanted.The patient was stable and the event resolved.Additional information received indicated the pump stayed flat when pressing the bulb.
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Event Description
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It was reported that the patient had the inflatable penile prosthesis pump component removed due to a malfunctioning, freezing pump as the pump stayed flat when pressing the bulb.A new inflatable penile prosthesis pump component was implanted.The patient was stable and the event resolved.
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Manufacturer Narrative
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H3 device evaluation: the ams 700 momentary squeeze (ms) pump was visually inspected; no leaks were found.The pump was functionally tested and failed the 8lb.Activation test.The pump therefore required more than 8lbs.Of force to activate.Product analysis therefore confirmed a pump malfunction.
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Search Alerts/Recalls
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